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Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME (ICOD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038125
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Diana Shechtman, OD FAAO, Retina Macula Specialists of Miami, LLC

Brief Summary:
The objective of this study is to test the hypothesis that following the use of intravitreal dexamethasone implant for the treatment of DME, there will be an observable increase in the capillary density plexus as denoted by the quantitative assessment of the superficial capillary plexus on OCTA, as well as a decrease in size of the foveal avascular zone (FAZ).

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Diabetic Retinopathy Retinal Ischemia Drug: Ozurdex Drug Implant Product Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME (RMSM ICOD STUDY)
Actual Study Start Date : August 22, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Ozurdex Implant
Intravitreal injection of Ozurdex implant
Drug: Ozurdex Drug Implant Product
Intravitreal Ozurdex injection
Other Name: Dexamethasone




Primary Outcome Measures :
  1. Evaluate re perfusion following Ozurdex use. [ Time Frame: 6 Months ]
    Determined by OCT-A



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years and Older.
  2. Diagnosis of diabetes mellitus (type 1 or type 2).
  3. At least one eye meets the study eye criteria listed.
  4. Visual Acuity 20/30 - 20/200 Snellen equivalent
  5. Have received no previous treatment for diabetic macular edema,(treatment naïve)
  6. Mild to Severe Non-proliferative Diabetic Retinopathy
  7. Diabetic macular edema present on optical coherence tomography (OCT) central subfield: ≥ 300µm.
  8. Able and willing to provide informed consent.

Exclusion Criteria:

  1. Have had any prior ocular treatment.
  2. Have had prior retinal surgical ( i.e. Pars plana vitrectomy). 3 .Have any clinical evidence of proliferative diabetic retinopathy.

4. Have a HBA1c of greater of 10%. 5. Evidence of Glaucoma or who are labeled glaucoma suspect at screening (defined as C/D >/= 0.5 with correlated NFLA thinning or IOP>25mmHg). 6. Have a contraindication to Ozurdex.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038125


Contacts
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Contact: Diana Shechtman, OD FAAO 954-816-1038 dshehctman@retinamiami.com
Contact: Pamela Garcia, CCRC 305-643-8871 pjimenez@retinamiami.com

Locations
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United States, Florida
Retina Macula Specialists of Miami, LLC Recruiting
North Miami Beach, Florida, United States, 33162
Contact: Joyce Gonzalez    305-655-0411    jgonzalez@retinamiami.com   
Contact: Pamela Garcia    306-643-8871    pjimenez@retinamiami.com   
Retina Macula Specialists of Miami, LLC Recruiting
South Miami, Florida, United States, 33143
Contact: Joyce Gonzalez    305-666-8850    jgonzalez@retinamiami.com   
Contact: Pamela Garcia    305-643-8871    Pjimenez@retinamiami.com   
Sponsors and Collaborators
Retina Macula Specialists of Miami, LLC
Allergan
Investigators
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Principal Investigator: Diana Shechtman, OD FAAO Retina Macula Specialists of Miami, LLC
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Responsible Party: Diana Shechtman, OD FAAO, Principal Investigator - OD, FAAO, Retina Macula Specialists of Miami, LLC
ClinicalTrials.gov Identifier: NCT04038125    
Other Study ID Numbers: LCH-0-012-019
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Diana Shechtman, OD FAAO, Retina Macula Specialists of Miami, LLC:
Diabetic Macula Edema
Diabetic Retinopathy
Retina Ischemia
Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Diabetic Retinopathy
Ischemia
Pathologic Processes
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents